Mechanical apparatus and method for artificial disc replacement

ABSTRACT

The present invention relates to a device and method to 1) facilitate disk fusing, 2) perform an artificial replacement of the nucleus, 3) perform an artificial replacement of the annulus, or 4, perform an artificial replacement of both the nucleus and annulus. The device is designed to be placed into the inter-vertebral space following diskectomy. The invention includes a delivery catheter and an expandable continuous mesh loop that has a torus configuration with a lumen within the mesh loop and a center hole. The mesh loop can be diametrically increased or contracted in diameter by the control element acting on the mesh loop. The mesh loop may be formed of a woven or braided material from a polymer such as PEEK (polyetheretherketone), nylon, polyurethane, polyester polyethylene, polypropylene or any other biocompatible polymers, or formed from a metallic braid of stainless steel, elgiloy, Nitinol, or any other biocompatible metals.

CROSS-REFERENCES

The present application is a continuation-in-part of patent applicationSer. No. 11/153,776 filed on Jun. 15, 2005, Ser. No. 11/173,034 filed onJul. 1, 2005 now U.S. Pat. No. 7,442,210 and Ser. No. 11/273,299 filedon Nov. 14, 2005. These applications are incorporated herein by thisreference.

FIELD OF THE INVENTION

The present invention generally relates to devices and methods for therepair of inter-vertebral discs. More, specifically, the presentinvention relates to devices and methods for the treatment of spinaldisorders associated with the nucleus, annulus and inter-vertebral disc.

BACKGROUND OF THE INVENTION

Inter-vertebral disc disease is a major worldwide health problem. In theUnited States alone almost 700,000 spine procedures are performed eachyear and the total cost of treatment of back pain exceeds $30 billion.Age related changes in the disc include diminished water content in thenucleus and increased collagen content by the 4^(th) decade of life.Loss of water binding by the nucleus results in more compressive loadingof the annulus. This renders the annulus more susceptible todelamination and damage. Damage to the annulus, in turn, acceleratesdisc degeneration and degeneration of surrounding tissues such as thefacet joints.

The two most common spinal surgical procedures performed are discectomyand spinal fusion. These procedures only address the symptom of lowerback pain. Both procedures actually worsen the overall condition of theaffected disc and the adjacent discs. A better solution would beimplantation of an artificial disc for treatment of the lower back painand to restore the normal anatomy and function of the diseased disc.

The concept of a disc prosthesis dates back to a French patent by vanSteenbrugghe in 1956. 17 years later, Urbaniak reported the first discprosthesis implanted in animals. Since this time, numerous prior artdevises for disc replacement have been proposed and tested. These aregenerally divided into devices for artificial total disc replacement orartificial nucleus replacement. The devises proposed for artificialtotal disc replacement, such as those developed by Kostuik, thatgenerally involve some flexible central component attached to metallicendplates which may be affixed to the adjacent vertebrae. The flexiblecomponent may be in the form of a spring or alternatively a polyethylenecore (Marnay). The most widely implanted total artificial disc to dateis the Link SB Charite disc which is composed of a biconvex ultra highmolecular weight polyethylene spacer interfaced with two endplates madeof cobalt-chromium-molybdenum alloy. Over 2000 of these have beenimplanted with good results. However device failure has been reportedalong with dislocation and migration. The Charite disc also requires anextensive surgical dissection via an anterior approach.

The approach of artificial nucleus replacement has several obviousadvantages over artificial total disc replacement. By replacing only thenucleus, it preserves the remaining disc structures such as the annulusand endplates and preserves their function. Because the annulus andendplates are left intact, the surgical procedure is much simpler andoperative time is less. Several nuclear prostheses can be place via aminimally invasive endoscopic approach. The nucleus implant in widestuse today is the one developed by Raymedica (Bloomington, Minn.) whichconsists of a hydrogel core constrained in a woven polyethylene jacket.The pellet shaped hydrogel core is compressed and dehydrated to minimizesize prior to placement. Upon implantation the hydrogel begins to absorbfluid and expand. The flexible but inelastic jacket permits the hydrogelto deform and reform in response to compressive forces yet constrain thehorizontal and vertical expansion (see U.S. Pat. No. 4,904,260 and4,772,287 to Ray). Other types of nuclear replacement have beendescribed which include either an expansive hydrogel or polymer toprovide for disc separation and relieve compressive load on the otherdisc components (see U.S. Pat. No. 5,192,326 to Boa). Major limitationsof nuclear prostheses are that they can only be used in patients in whomdisc degeneration is at an early stage because they require the presenceof a competent natural annulus. In discs at later stages of degenerationthe annulus is often torn, flattened and/or delaminated and may not bestrong enough to provide the needed constraint. Additionally, placementof the artificial nucleus often requires access through the annulus.This leaves behind a defect in the annulus through which the artificialnucleus may eventually extrude compressing adjacent structures. What isclearly needed is a replacement or reinforcement for the natural annuluswhich may be used in conjunction with these various nuclear replacementdevices.

Several annular repair or reinforcement devices have been previouslydescribed. These include the annulus reinforcing band described by U.S.Pat. No. 6,712,853 to Kuslich, which describes an expansile bandpressurized with bone graft material or like, expanding the band. U.S.Pat. No. 6,883,520B2 to Lambrecht et al, describes a device and methodfor constraining a disc herniation utilizing an anchor and membrane toclose the annular defect. U.S. patent application Ser. No. 10/676868 toSlivka et al. describes a spinal disc defect repair method. U.S. Pat.No. 6,806,595 B2 to Keith et al. describes disc reinforcement byimplantation of reinforcement members around the annulus of the disc.U.S. Pat. No. 6,592,625 B2 to Cauthen describes a collapsible patch putthrough an aperture in the sub-annular space. U.S. patent applicationSer. No. 10/873,899 to Milbocker et al. describes injection of in situpolymerizing fluid for repair of a weakened annulus fibrosis orreplacement or augmentation of the disc nucleus.

Each of these prior art references describes devices or methods utilizedfor repair of at least a portion of the diseased annulus. What isclearly needed is an improved spinal disc device and method capable ofreinforcing the entire annulus circumferentially. In addition what isclearly needed is a spinal disc device and method which may be easilyplaced into the inter-vertebral space and made to conform to this space.What is clearly needed is an improved spinal disc device and methodcapable of reinforcing the entire annulus that may be utilized either inconjunction with an artificial nucleus pulposis or may be used as areinforcement for the annulus fibrosis and as an artificial nucleuspulposis.

SUMMARY OF THE INVENTION

The present invention addresses this need by providing improved spinaldisc device and methods for the treatment of inter-vertebral discdisease. The improved device and methods of the present inventionspecifically address disc related pain but may have other significantapplications not specifically mentioned herein. For purposes ofillustration only, and without limitation, the present invention isdiscussed in detail with reference to the treatment of damaged discs ofthe adult human spinal column.

As will become apparent from the following detailed description, theimproved spinal disc device and methods of the present invention mayreduce if not eliminate back pain while maintaining near normalanatomical motion. The present invention relates to devices and methodswhich may be used to reinforce or replace the native annulus, replacethe native nucleus, replace both the annulus and nucleus or facilitatefusion of adjacent vertebrae. The devices of the present invention areparticularly well suited for minimally invasive methods of implantation.The spinal disc device is a catheter based device which is placed intothe inter-vertebral space following discectomy performed by eithertraditional surgical or endoscopic approaches. The distal end of thecatheter is comprised of an expansile loop or mesh which may beincreased in diameter by either advancement or retraction of a controlelement comprising a flexible portion of the catheter which may bemanipulated by its proximal end, such proximal end remaining external tothe body. The expansile loop or mesh may be formed of a woven, knittedor braided material and may be made of Nylon, Dacron, syntheticpolyamide, polyetheretherketone (PEEK), expanded polytetrafluroethylene(e-PTFE), polyethylene and ultra-high molecular weight fibers ofpolyethylene (UHMWPE) commercially available as Spectra™ or Dyneema™, aswell as other high tensile strength materials such as Vectran™, Kevlar™,natural or artificially produced silk and commercially available suturematerials used in a variety of surgical procedures. Alternatively theexpansile loop or mesh portion of the catheter may be made of abiodegradable or bioabsorbable material such as resorbable collagen,LPLA (poly(l-lactide)), DLPLA (poly (dl-lactide)), LPLA-DLPLA, PGA(polyglycolide), PGA-LPLA or PGA-DLPLA, polylactic acid and polyglycolicacid which is broken down and bioabsorbed by the patient over a periodof time. Alternatively the expansile portion of the catheter may beformed from metallic materials, for example, stainless steel, elgiloy,Nitinol, or other biocompatible metals. Further, it is anticipated thatthe expansile loop portion of the device could be made from a flattenedtubular knit, weave, mesh or foam structure.

The expansile loop may be formed such that when the loop isdiametrically contracted one end of the loop feeds into its other end,similar to a snake eating its own tail. Alternatively, the expansileloop may be formed such that when it is diametrically contracted it isin the shape of a toroid invaginating into itself. Stabilization of theouter portion of the loop and pulling out the inner portion will therebyincrease the overall diameter of the loop while maintaining it as asubstantially closed loop or toroid.

In one embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered and expandedwithin the vertebral space to the limits of the inner portion of thenative annulus to reinforce or artificially replace the native annulus.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered and expandedwithin the vertebral space to the limits of the inner portion of thenative annulus and then an injection of polymeric or hydrogel or likematerial is conducted to reinforce or artificially replace the nativeannulus.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered and expandedwithin the vertebral space to the limits of the inner portion of thenative annulus and then the inner portion of the present invention iscentrally expanded to the limits of an artificial nucleus concurrentlyor previously placed within the inter-vertebral space.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered within thevertebral space and into the area of the nucleus, which may have beenpreviously removed, and expanded to the limits of the outer portion ofthe area of the native nucleus and then injected with a polymer orhydrogel or like material conducted to reinforce or artificially replacethe native nucleus.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered within thevertebral space and expanded within the vertebral space to the limits ofthe outer portion of the native annulus and then an injection ofpolymeric or hydrogel material is conducted to reinforce or artificiallyreplace the native annulus. Then the present invention is delivered intothe nucleus area and expanded to the limits of the outer portion of thenative nucleus or an artificial nucleus concurrently placed and then aninjection of polymeric or hydrogel material is conducted to reinforce orartificially replace or reinforce the nucleus.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is first delivered and expandedwithin the vertebral space and expanded inward from the outer limits ofthe annulus to the point where essentially no central hole remains inthe toroid and a polymeric or hydrogel or like material is injected intothe expanded mesh.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is delivered and expanded withinthe vertebral space and then an injection of a bone graft material,polymeric bone graft compound, or material inducing or promoting thegrowth of bone such as, but not limited to growth factors, BMP or likeis conducted in order to facilitate the fusion of an adjacent vertebrae.

In another embodiment, the present invention consists of a device andmethod, whereby the present invention is delivered and expanded withinthe vertebral space surrounding previously or concurrently placed bonegraft material, polymeric bone graft compound, or material inducing orpromoting the growth of bone such as, but not limited to growth factors,BMP or like in order to facilitate the fusion of an adjacent vertebrae.

The present invention and variations of its embodiments is summarizedherein. Additional details of the present invention and embodiments ofthe present invention may be found in the Detailed Description of thePreferred Embodiments and Claims below. These and other features,aspects and advantages of the present invention will become betterunderstood with reference to the following descriptions and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-section view of one embodiment of the presentinvention with the control element attached to the interior distal endof the expansile loop and in a contracted delivery configuration.

FIG. 2 is a cross-sectional of one embodiment of the present inventionwith the control element attached to the interior distal end of theexpansile loop and with the sheath retracted and the expansile loopexposed.

FIG. 3 is a cross-section view of one embodiment of the presentinvention with the control element attached to the interior distal endof the expansile loop and with the expansile in an expandedconfiguration.

FIG. 4 is a cross-section of the one embodiment of the present inventionwith the control element attached to the interior distal end of theexpansile loop and with the expansile loop in an expanded and the innercircumference of the expansile loop in a contracted configuration.

FIG. 5 is a magnified cross-section view from FIG. 4 of the presentinvention with the control element attached to the interior distal endof the expansile loop and showing the controlling end of the expansileloop.

FIG. 6 is a cross-section view of another embodiment of the presentinvention with the control element exiting the sidewall of the outersection of the expansile loop and releasably connecting to the proximalportion of the outer section of the expansile loop and with theexpansile loop shown in a contracted delivery configuration.

FIG. 7 is a cross-sectional view of another embodiment of the presentinvention with the sheath retracted and the expansile loop exposed.

FIG. 8 is a cross-section view of the embodiment of FIG. 1 with theexpansile loop in an expanded configuration.

FIG. 9 is a magnified cross-section view from FIG. 8 of the presentinvention showing the controlling end of the expansile loop.

FIG. 10 is a cross-section view of another embodiment of the presentinvention with two control elements and in a contracted deliveryconfiguration.

FIG. 11 is a cross-sectional of another embodiment of the presentinvention with two control elements and with the sheath retracted andthe expansile loop exposed.

FIG. 12 is a cross-section view of another embodiment of the presentinvention with two control elements and with the expansile loop in anexpanded configuration.

FIG. 13 is a cross-section of another embodiment of the presentinvention with two control elements and with the expansile loop in anexpanded and the inner circumference of the expansile loop in acontracted configuration.

FIG. 14 is top view cross-section view of a spinal body (vertebrae)showing the posterolateral access tube advanced into the inter-vertebralspace.

FIG. 15 is a top view cross-section view of a spinal body (vertebrae)with one of the embodiments of the present invention being positionedwithin the inter-vertebral space of the spinal body (vertebrae).

FIG. 16 is a top view cross-section of a spinal body (vertebrae) withone of the embodiments of the present invention expanded and surroundingthe nucleus section of the spinal body (vertebrae).

FIG. 17 is top view cross-section of a spinal body (vertebrae) with oneof the embodiments of the present invention's outside diameter expandedand the inside diameter contracted within the inter-vertebral space ofthe spinal body (vertebrae).

FIG. 18 is a cross-section dimensional view of the expansile loop in apartially expanded configuration with a diameter D and a height H.

FIG. 19 is a cross-sectional dimensional view of the expansile loop inan expanded configuration with the diameter increasing +D and the heightincreasing +H.

FIG. 20 is a cross-section view of another embodiment of the presentinvention with the expansile loop in an invaginated configuration(whereby a portion of the expansile loop is bent back and enteringitself) with the expansile loop in a partially expanded configuration.

FIG. 21 is a cross-sectional view of additional feature of the presentinvention with an inner catheter or control element having a pluralityof holes for delivery and injection of biomaterials.

FIG. 22 is a perspective view of an element of the present inventionwhereby locking elements on the distal end of the expansile interiorloop are engaged to the expansile outer loop.

FIG. 23 is a cross sectional view of the attachment means in the from ofa suture and demonstrating a suture delivery system already advancedthrough an access tube and utilizing non-absorbable or re-absorbablesutures to attach the contracted configuration of the expansile mesh tothe inner wall of the annulus at multiple points.

FIG. 24 shows a cross sectional view of the attachment means in the formof a staple or helicoil with a delivery system already advanced throughthe access tube and utilizing non-absorbable or re-absorbable stables orhelicoil mechanism to secure the expanded expansile mesh to the innerwall of the annulus at multiple points. Also shown are non-absorbable orre-absorbable stables or helicoils used to attach the expanded expansilemesh to the outer wall of an artificial nucleus at multiple points.

FIG. 25 shows a cross sectional view of the expansile mesh containedwithin a vertebral bone structure with the mesh attached to the bonestructure by means of screws or anchors.

FIG. 26 is a top view cross-section view of a spinal body (vertebrae)with one of the embodiments of the present invention being positionedwithin the inter-vertebral space of the spinal body (vertebrae) fordelivering a biomaterial or bone chips inside the expansile mesh.

FIG. 27 is a top view cross-section of a spinal body (vertebrae) withone of the embodiments of the present invention expanded and surroundingthe portion of the spinal body (vertebrae) where the nucleus has beenpreviously removed.

FIG. 28 is top view cross-section of a spinal body (vertebrae) with oneof the embodiments of the present invention's outside diameter expandedand the inside diameter contracted within a delivery probe beinginserting through the and advanced towards the inside of the expansilemesh.

FIG. 29 is top view cross-section of a spinal body (vertebrae) with oneof the embodiments of the present invention's outside diameter expandedand the inside diameter contracted within the inter-vertebral space ofthe spinal body (vertebrae), a delivery probe inserted through theexpansile mesh whereby a biomaterial or bone chips are being deliveredto the area inside the expansile mesh.

FIG. 30 is a section taken from FIG. 29 showing the expasile mesh havingan original non-disturbed cross-pattern configuration.

FIG. 31 is a section taken from FIG. 29 showing the capability of theexpansile mesh to flex open and allow the inserting of a delivery probe.

FIG. 32 is top view cross-section of a spinal body (vertebrae) whereinone of the embodiments of the present invention's includes a bone blockdelivery apparatus having a shaft that is coaxially engaged with a firsttubular member and a second tubular member, further wherein the shaftmember has a terminal end with an attachment means temporally engagedwith a bone block that is enclosed within the present inventionexpansile loop in a contracted configuration.

FIG. 33 is top view cross-section of a spinal body (vertebrae) whereinone of the embodiments of the present invention's includes a bone blockdelivery apparatus having a shaft that is coaxially engaged with a firsttubular member and a second tubular member, further wherein the shaftmember has a terminal end with an attachment means temporarily engagedto a bone block and enclosed within the present invention expansile loopin a contracted configuration and being positioned within theinter-vertebral space.

FIG. 34 is top view cross-section of a spinal body (vertebrae) whereinone of the embodiments of the present invention's includes a bone blockdelivery apparatus having a shaft that is coaxially engaged with a firsttubular member and a second tubular member, further wherein the shaftmember has a terminal end with an attachment means temporarily engagedto a bone block and enclosed within the present invention expansile loopin a circumferentially expanded configuration while positioned withinthe inter-vertebral space.

FIG. 35 is top view cross-section of a spinal body (vertebrae) whereinone of the embodiments of the present invention's includes a bone blockdelivery apparatus having a shaft that is coaxially engaged with a firsttubular member and a second tubular member, further wherein the shaftmember has a terminal end with an attachment means disengaged from abone block that is enclosed within the present invention expansile loopin a expanded configuration while positioned within the inter-vertebralspace.

FIG. 36 is top view cross-section of a spinal body (vertebrae) whereinone of the embodiments of the present invention's wherein the shaft(shown retracted) or other instrument (not shown) urges the bone blockto move from a vertical position to a horizontal along the anterior wallof the annulus.

FIG. 37 is top view cross-section of a spinal body (vertebrae) with oneof the embodiments of the present invention's includes a bone blockdelivery apparatus that delivers a plurality of bone chips or materialsto the inter-vertebral space.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

One embodiment 10, 11 of the spinal disc device, as shown in FIGS. 1-5,consists of an elongated probe 15, with a proximal end 17 and a distalend 16. Referring to FIGS. 1 and 2, is can be seen that the elongatedprobe 15 is constructed from at least two elements, a flexible innercatheter control element 19, and a stiffer outer catheter element 12.The inner catheter control element 19 is slideably located within theouter catheter element 12. At the proximal end 17 of elongated probe 15,the inner catheter control element 19 exits from the outer catheterelement 12, and can be advanced or retracted causing the distal end 20of the inner catheter control element 19 to move in or out of the distalend 13 of the outer catheter element 12. Near the distal end 16 of theelongated probe 15, is situated an expansile, braided, woven orembroidered tubular loop 24 in a contracted or delivery configuration(FIG. 1). The inner catheter control element 19 enters the expansileloop 24 near the distal end 13 of the outer catheter element 12 andslideably resides within the expansile loop 24. The distal end 22 of theexpansile loop 24 is fed into the proximal end 23, of the expansile loop24 in a manner similar to a snake eating its own tail. This results inan expansile loop 24 with an inner section and outer section as shown inFIGS. 1 and 2. A covering retractable sheath 18 is placed over theelongated probe 15 to hold it in a constrained condition for deliveryinto the vertebral disc. After the sheath 18 is retracted, the expansileloop 24 may be increased in circumferential diameter by withdrawing thedistal end 22 of the expansile loop 24 from the proximal end 23 of theouter expansile loop 24 (FIG. 3). In this configuration, a substantiallycontinuous interior chamber 28 is now defined within the expandedexpansile loop 25. The outer catheter element 12 terminates at itsdistal end 13 and is removeably attached to the proximal end 23 of theouter section of the expanded expansile loop 25. The inner cathetercontrol element 19, in the form of a filament, guidewire or flexibletube, slideably extends from the proximal end 17 of the catheter orprobe 15, through the outer catheter element 12, and exiting the outercatheter element at its distal end 13. The inner catheter element thenenters the inside of the outer section of the expansile loop at itsproximal end 23. The inner catheter control element 19 may be loopedone, less than one, or more than one time within the expansile loop 24,25 between the inner and outer portions of the loop prior to the innercatheter element 19 or control element terminating within the expansileloop 24, 25 at its distal end 22, 26. The inner catheter control element19 is then attached to the expansile loop 24, 25 at the distal end 22,26 of the inner section of the expansile loop 24, 25.

The inner catheter control element 19 can be made of a flexible yetlongitudinally incompressible material such as, but not limited to, astainless steel or Nitinol wire of 0.010″-0.040″ diameter. Slidablyadvancing the inner catheter element 19 through the outer catheterelement 12 while holding the proximal portion of the outer section ofthe expansile loop 23, 27 in place will result in the inner section ofthe expansile loop 24, 25 pulling out of the outer section of theexpansile loop 24, 25 thereby providing mechanical expansion without theuse of pressurization. This will result in the overall diametricexpansion of the expansile loop 24, 25 and forming a continuous meshloop resembling a toroidal configuration . This toroidal configurationhas a continuous inner chamber and an inner central area. As shown inFIG. 4, once expansion of the outer circumference of the expansile loop25 is achieved and fixed, pulling out the inner catheter control element19 while holding the outer section 27 of the expansile loop 25 fixed,contracts the inner circumference of the expansile loop 25 whileexpanding its height. Expansion of the expansile loop 25 into thevertebral space is achieved by the spring nature of the expansile loop's24, 25 material construction or by advancing the inner catheter controlelement 19 while holding the proximal outer section of the expansileloop 23 fixed. Next, pulling on the inner catheter control element 19while holding the proximal outer section 27 of the expansile loop 25fixed, the interior circumference of the expansile loop 25 contractstoward the center of the expansile loop 25 while the height of theexpansile loop 25 increases.

FIG. 5 is a magnified cross-section view from FIG. 4 of this presentinvention embodiment with the control element attached to the interiordistal end 26 of the expansile loop 25. This Figure shows thecontrolling end of the expansile loop 25 and the physical relationshipbetween the distal end 20 of the inner catheter 19, distal 26 andproximal end 27 of the expansile loop 25, and outer catheter element 12.

The outer catheter element 12 used for delivery of the expansile loop 24should be sufficiently stiff to allow retraction of the inner cathetercontrol element 19 without collapse or kinking. The inner cathetercontrol element 19 must be sufficiently flexible to circle around theexpansile loop 24 and attain a relatively small radii without kinkingyet have sufficient tensile strength to resist breakage when pulled fromits proximal sections. The outer catheter element 12 can be fabricatedfrom polymeric materials including, but not limited to, Nylon, Dacron,synthetic polyamide, polyetheretherketone (PEEK), expandedpolytetrafluro-ethylene (e-PTFE), polyethylene and ultra-high molecularweight fibers of polyethylene (URMWPE), or metallic materials, includingbut not limited to, stainless steel,cobalt-chrome alloy, titanium,titanium alloy, or nickel-titanium shape memory alloys among others thathave sufficient kink resistance and tensile strength. The inner cathetercontrol element 19 can be manufactured from Nylon, Dacron, syntheticpolyamide, polyethereketone (PEEK), expanded polytetrafluro-ethylene(e-PTFE), polyethylene and ultra-high molecular weight fibers ofpolyethylene (UHMWPE) or from metallic materials including, but notlimited to stainless steel, cobalt-chrome alloy, titanium, titaniumalloy, or nickel-titanium shape memory alloys, among others. Theelements manufactured from metallic materials have a diameter from0.001″ to 0.020″ and preferably from 0.004″ to 0.010″. The elementsmanufactured from polymeric materials have a diameter from 0.005″ to0.040″ and a preferred diameter from 0.010″ to 0.020″.

The expansile loop 24, 25 is fabricated as a knit, weave or braid andcan be constructed from non-degradable materials. Suitablenon-degradable materials for the expansile loop 24, 25, include, but arenot limited to, Nylon, Dacron, synthetic polyamide, polyetheretherketone(PEEK), expanded polytetrafluroethylene (e-PTFE), polyethylene andultra-high molecular weight fibers of polyethylene (UHMWPE) commerciallyavailable as Spectra™ or Dyneema™, as well as other high tensilestrength materials such as Vectran™, Kevlar™, natural or artificiallyproduced silk and commercially available suture materials used in avariety of surgical procedures. The expansile loop 24, 25 fabricated asa weave or braid and can be constructed from biodegradable orbioabsorbable materials Suitable biodegradable and bioabsorbablematerials for the expansile loop 24, 25 include, but are not limited to,resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly (dl-lactide)),LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, andbiodegradable sutures made from polylactic acid and polyglycolic acid.

In addition, for some embodiments, suitable metallic materials for theexpansile loop 24, 25 may be used that include, but are not limited to,stainless steel, cobalt-chrome alloy, titanium, titanium alloy, ornickel-titanium shape memory alloys, among others. It is furthercontemplated that the metallic mesh can be interwoven withnon-resorbable polymers such as nylon fibers, carbon fibers andpolyethylene fibers, among others, to form a metal-polymer compositeweave. Further examples of suitable non-resorbable materials includeDACRON and GORE-TEX. One feature of the expansile loop 24, 25 is that itneeds to have pore sizes or openings that are small enough to hold thefilling material or nucleus from extruding out and large enough tomaintain flexibility and expansion characteristics.

In another embodiment the distal end 13 of the outer catheter element 12resides around the inner catheter control element 19. The outer catheterelement 12 is held in a constant relationship or releaseably affixed tothe proximal end 23 of the outer section of the expansile loop 24. Inthis embodiment the inner catheter control element 19 is in the form ofa very flexible element which enters the proximal opening in the outsidesection of the expansile loop 23, loops one, less than one or more thanone time around the inside of the outside section of the expansile loop24 and terminates attaching at the distal end 22 of the inside sectionof the expansile loop 24. The direction of rotation of the flexiblecontrol element 19 (measured from distal end of the control element 20to the proximal end 21 is in the opposite rotational direction as thedirection of rotation of the inside section of the expansile loop 24,asit enters and loops around the outside section of the expansile loop 24.Upon retraction of the proximal end 21 of the inner catheter controlelement 19, back out of the outer catheter element 12, the distal end 13of the outer catheter element 12 stabilizes and holds the outer section23 of the expansile loop 24 in place while the inner section 22 of theexpansile loop 24 is pulled out of the outer section, resulting in anincrease in the diameter of the expansile loop 24. Once the expandedexpansile loop 25 has reached its maximum diameter, determined either bythe confines of the space into which it is expanding or by the exitpoint of the control filament through the proximal end 27 of theexpanded expansile loop 25, continued retraction of the inner cathetercontrol element 19 will result in the inner catheter control element 19producing tension on the inner circumference of the expanded expansileloop 25. The inner circumference of the expanded expansile loop 25 willcontract towards the middle of the expanded expansile loop 25 and theexpanded expansile loop's 25 height will increase. Due to the woven,braided or embroidered nature of the tubular expansile loop 24, 25, theexpanded expansile loop 25, will remain generally in the shape of atoroid both upon its circumferential expansion and its centralcontraction.

An additional embodiment 39, 40 of the expansile loop device used forrepair or replacement of the annulus fiborosis of the spine can beunderstood by referring to FIGS. 6-9. As shown in FIGS. 6-8, the innercatheter control element 19 is looped around and exits through the wallof the outer section of the expansile braided, woven or embroidered loop24 near the attachment of the outer catheter element 12 to the proximalend 23 of the outer section of the expansile loop 24. The inner cathetercontrol element 19 is then affixed to the outer catheter element 12, atthis point using either a knot or a releasable or removable junction orpasses proximally through the outer catheter element 12. A coveringretractable sheath 18 is placed over the elongated probe 15 to hold itin a constrained condition for delivery into the vertebral disc. Afterthe sheath 18 is retracted, a “snare” or loop is formed by the proximalportion of the inner catheter control element 19 being slideably locatedwithin the outer catheter element 12 and the expansile loop 24. If theinner catheter control element 19 is of sufficient stiffness, forexample but not limited to, a metallic guidewire of 0.010″-0.040″diameter, the snare and the expansile loop 24 may be opened by advancingthe proximal portion 21 of the inner catheter control element 19 whileholding the outer catheter element 12 and the proximal end of theexpansile loop 23 in place. This opening of the circumference of thesnare formed by the inner catheter control element 19 will result in anexpansion of the circumference of the expansile loop 24 as the innerportion of the expansile loop 24 pulls out of its outer portion. Oncethe limits of expansion of the expanded expansile loop 25 have beenreached, the inner catheter control element 19 may be detached at thejunction or connection of the outer catheter 12 and the proximal end ofthe expanded expansile loop 27 and slideably retracted out of theexpanded expansile loop 25 leaving behind a circumferentially expandedexpansile loop 25.

In an alternative embodiment of the present invention for annular repairor replacement, the inner catheter control element 19 is run inside ofthe expansile loop 24, 25 which is looped and exits first the distal endof the inner section of the braided, woven or embroidered loop 22, 26and then exits through the wall of the outer portion of the braided,woven or embroidered loop 23, 27 prior to its attachment to outercatheter element 12. The inner catheter control element or filament 19may make one, less than one or more than one loop inside of theexpansile loop 24, 25 prior to exiting and attaching to catheter element12. In this manner the inner catheter control element 19 forms a “snare”or loop of one or multiple turns. If the inner catheter control element19 is of sufficient stiffness, for example but not limited to, ametallic guidewire of 0.010″-0.040″ diameter, the snare may be opened byadvancing the proximal portion of the inner catheter control element 19while holding the outer catheter element 12 and proximal end of theexpansile loop 23, 27 in place. This opening of the circumference of oneor more loops of the snare formed by the inner catheter control element19 will result in an expansion of the circumference of the expansileloop 24, 25 as the inner portion of the expansile loop 24, 25 pulls outof its outer portion. Once the limits of expansion of the expansile loop24, 25 have been reached, the inner catheter control element 19 may bepulled back into the catheter element 12 by pulling on its proximalportion 21. This causes one or more loops of the snare becoming smallerpulling on the inner circumference of the expanded expansile loop 25resulting in a contraction of the central space in the middle of theexpanded expansile loop 25 without the use of pressurization. Due to thebraided, woven or embroidered nature of the expansile loop 24, 25, theexpansile loop 24, 25, will remain generally in the shape of a toroidalconfiguration both upon its circumferential expansion and its centralcontraction. This toroidal configuration has a continuous inner chamberand an inner central area.

In an alternative embodiment of the present invention for annular repairor replacement, the inner catheter control element 19 is run inside ofthe expansile loop 24, 25 which is looped and exits first the distal endof the inner section of the braided, woven or embroidered loop 22, 26and then exits through the wall of the outer portion of the braided,woven or embroidered loop 23, 27. Prior to exiting through the wall ofthe outer portion of the braided, woven or embroidered loop, the innercatheter control element 19 may pass through a slip-lock attached to themore proximal portion of the control element, thereby forming a snareloop with itself. This slip lock may allow the control element to lockin place as the snare is contracted in circumference, similar to a “tiewrap” or cable wrap, commonly used to hold cables together. This snaremay be opened by advancing the proximal portion of the inner cathetercontrol element 21 while holding the slip lock portion in place. Thisopening of the circumference of one or more loops of the snare formed bythe inner catheter control element 19 will result in an expansion of thecircumference of the expansile loop 24, 25 as the inner portion of theexpansile loop 24, 25 pulls out of its outer portion. Once the limits ofexpansion of the expansile loop 24, 25 have been reached, the innercatheter control element 19 may be pulled back into the catheter element12 by pulling its proximal portion 21 through the slip lock. This causesone or more loops of the snare becoming smaller pulling on the innercircumference of the expanded expansile loop 25 resulting in acontraction of the central space in the middle of the expanded expansileloop 25. Due to the braided, woven or embroidered nature of theexpansile loop 24, 25, the expansile loop 24, 25, will remain generallyin the shape of a toroid both upon its circumferential expansion and itscentral contraction.

As shown in FIGS. 10-13, another embodiment 43, 44 of the presentinvention comprises an elongated probe 15, with a proximal end 17 and adistal end 16. Referring to FIGS. 10 and 11, a first inner cathetercontrol element 19 is slideably located within the outer catheterelement 12. At the proximal end 17 of elongated probe 15, the innercatheter control element 19 exits from the outer catheter element 12,and can be advanced or retracted causing the distal end 20 of the innercatheter control element 19 to move in or out of the distal end 13 ofthe outer catheter element 12. The first inner catheter control element19, in the form of a filament, guidewire or flexible tube, slideablyextends from the proximal end 17 of the probe 15, through the lumen ofthe outer catheter element 12, and exiting the outer catheter element 12at its distal end 13. The inner catheter control element 19 then entersthe inside of the outer section of the expansile loop 24 at its proximalend 23. The inner catheter control element 19 may be looped one, lessthan one, or more than one time within the expansile loop 24 between theinner and outer portions of the expansile loop 24 prior to the innercatheter element or control element 19 terminating within the expansileloop 24. The inner catheter control element 19 is then attached to theexpansile loop 24 at its distal end 22. This embodiment also includes asecond inner catheter control element 52 which extends from the proximalend 17 of the catheter or probe 15, through the outer catheter element12, and exiting the outer catheter element 12 at its distal end 13. Thesecond inner catheter control element 52 then enters the outside of theouter section of the expansile loop 24 and is attached to the distal end22 of the expansile loop 24. A covering retractable sheath 18 is placedover the elongated probe 15 to hold it in a constrained condition fordelivery into the vertebral disc. After the sheath 18 is retracted, thesecond interior catheter control element 52 is pulled back into theouter catheter control element 12 by pulling on its proximal end. Thiscauses the distal end of the expansile loop 22 to be pulled from insidethe outer portion of the expansile loop 24 expanding the outercircumference of the expansile loop 24 (See FIG. 12). Now referring toFIG. 13, the first inner catheter control element 19 may be pulled backinto the outer catheter element 12 by pulling on its proximal end. Thiswill result in a pulling in of the center of the expansile loop 25towards the middle of the loop and contraction of central space in themiddle of the expansile loop 25 without the use of pressurization. Dueto the braided, woven or embroidered nature of the tubular expansileloop 24, 25, the expansile loop 24, 25, will remain generally in theshape of a toroidal configuration both upon its circumferentialexpansion and its central contraction. This toroidal configuration has acontinuous inner chamber and an inner central area.

In another embodiment 59, 60 as represented in FIGS. 18-20, thecontracted configuration of the expansile loop 58 comprises an expansileloop 58 which has a portion folding back into itself or invaginated 56(see FIG. 20). This forms a complete toroid with a portion invaginatedto form a diametrically contracted toroid with an inner section and anouter section that are continuous with each other. Pulling on the innercatheter control element 19 in the manner previously described willfunction to increase the diameter (+D) and increase the height (+H) ofthe expanded expansile loop 25 as the central portion of the toroid ispulled towards the center.

The entire expansile loop assembly 10 including the circumferentiallycontracted braided, woven or embroidered expansile loop 24, and innercatheter control element 19, may now be compressed into the distal outercatheter element, a sheath 18 or alternatively into an access tube 38 ofapproximately 3-20mm diameter for ease of placement. The access tube 38may be formed from any suitable material, as the present invention isnot limited in this respect. Thus, the access tube 38 may be formed froma plastic material, such as a polycarbonate, or a metal material, suchas stainless steel, or any suitable combination of materials. Inaddition, the postero-lateral access tube 38 may be formed of a materialthat can be readily sterilized. Further, the elongated probe 15 may beformed as a single use device such that resterilization is not requiredafter use. The posterlateral access tube 38 gains access to thevertebrae generally using a posterior approach (FIG. 14).

As shown in FIG. 15, the posterlateral access tube 38 has gained accessto the vertebrae 32, having a spinal cord 33, an annulus 36 and anucleus area 34. Once in proper position in the vertebrae 32 of apatient, the expansile loop 24 may be ejected into the nucleus area 33or the annulus area (not shown in this Figure) from the distal end ofthe outer catheter element 13, sheath 18 or access tube 38 by retractingthe outer catheter element 12 or sheath 18 and simultaneously holdingthe inner catheter 19 and expansile loop 24 in a fixed position.Alternatively, an additional “pusher” element (not shown) can beadvanced distally into the outer catheter element 12 or sheath 18 oraccess tube and eject the expansile loop 24, catheter element 12 and thedistal inner catheter control element 20 from the end of the sheath 18.As previously described in the embodiments above, the expansile loop 24may now be circumferentially expanded by either pulling on or pushingthe inner catheter control element 19 in the manner described above.Furthermore, if it is desired that the central portion of the braided,woven or embroidered expansile loop 24 become circumferentiallycontracted, pulling on the inner catheter control element 19 asdescribed above will accomplish this feature.

Now referring the FIG. 16, the expanded expansile loop 25 achieves thedesired outer circumferentially expanded and inner circumferentiallycontracted size 48, when the inner catheter control element 19 is lockedor tied in place with a knot. This can also be accomplished by a lockingjunction located at the outer catheter element 12. The distal portions20 of the external inner catheter control element 19 can now bedisconnected or cut from a connector or proximal to the knot. Theconnector or knot is also separated from the distal outer catheterelement 12. This then leaves an outer circumferentially expanded andinner circumferentially contracted expansile loop 25 in place as aclosed loop in the desired location (shown in FIG. 16 expanded with thenucleus area 34) within the inter-vertebral space.

As represented in FIG. 21 an additional feature of the present inventionwith an inner catheter control element 41 having a plurality of distalholes 42 for delivery and injection of biomaterials which can beutilized with the embodiments of the present invention. The innercatheter control element 41 with holes 42 comprises a tubular structurewith a central lumen from the proximal end 17 of the outer catheterelement 12 communicating with side holes in the distal end 13. Theproximal end of the inner catheter or control element may be fitted withan injection device (e.g. syringe). The inner catheter control element41 is contained within the continuous interior chamber of the expandedexpansile loop 58. The holes 42 in the inner catheter control element 41are designed to be only within the continuous inner chamber.Furthermore, it is anticipated that the holes can be of different sizealong the length of the inner catheter control element to equalizebiocompatible material delivery (e.g. larger holes at the distal end,smaller holes at the proximal end). In addition, it is anticipated thatthe holes can be in various configurations, e.g. oval, or can be aplurality of slots or other similar opening.

FIG. 22 is another feature of the present invention that can be usedwith several of the embodiments 11, 44, 60, 62 whereby non-permanentlocking elements 30 on the distal end of the expansile interior loop areengaged to the distal end 26 of the expansile outer loop. The lockingelements are extended portions of one end of the braid or loop whichinterlock with the braid or loop pattern. The locking elements functionto maintain a desired diameter of the expansile loop after expansion.

In one method of clinical use, the nucleus of the damaged disc has beenpreviously removed by discectomy techniques either through an anterior,posterior or posterolateral surgical approach. The expansile loopannular repair or replacement device 10 in its compressed configurationwithin the outer catheter element 12 or sheath 18 is advanced through anaccess tube or cannula previously placed into the inter-vertebral space.This cannula may access the inter-vertebral space from a posterior,posterolateral or anterior approach that is well known to physiciansskilled in the art. The present invention 10 is then advanced into theinter-vertebral space through the access tube 38. Once the distalexpansile loop 24 is advanced through the access tube 38 into thevertebral space it is diametrically expanded by either retraction oradvancement of the inner catheter control element 19 in the mannerpreviously described. The distal expansile loop 25 expands to the limitsof the inner portion of the remains of the native annulus and remainsdiametrically expanded and transversely contracted as illustrated inFIG. 6. Any of a number of previously described artificial nuclei puposimay then be placed in the center of the diametrically expanded expansileloop 48 either via direct visualization from the traditional surgicalapproach or via endoscope from a posterolateral approach through theforamina or form a posterior approach. These artificial nuclei may thenbe allowed to expand either through the absorption of liquids, as is thecase for hydrogel based devices, or through the injection of materialinto the nuclear prosthesis.

Once the nuclear replacement is in place, any remaining space betweenthe nuclear replacement and the expansile loop annular replacementdevice may be reduced or eliminated by centrally contracting the innercircumference of the toroid formed by the expansile loop device. This isaccomplished in the manner previously described by pulling back theinner catheter control element resulting in contraction of the innercircumference of the device until it abuts the nuclear replacement. Thebraided, woven or embroidered design of the expansile loop 48 will alsoallow it to flex and bend to conform to the inter-vertebral space. Byproperly selecting the material from which the expansile braided, wovenor embroidered loop is constructed and by properly selecting the designof braid for its manufacture as previously described, the expansilebraided, woven or embroidered loop will now function as a completecircumferential support for the artificial nucleus. The expansilebraided, woven or embroidered loop will prevent extrusion of theartificial nucleus through any defects in the remaining native annulusand act to stabilize the artificial nucleus during both bending andmotion of the spine and throughout the healing process. The braided,woven or embroidered design of the expansile loop will also permit it toflexibly bend as the central nucleus replacement expands and swells toits final size. The braided, woven or embroidered design of theexpansile loop will also permit tissue in growth to occur as healingoccurs. This will result in stabilization of the artificial nucleus.

In an alternative method, once the expansile braided, woven orembroidered loop 48 has been expanded to fill the inter-vertebral spacebetween the artificial nucleus and the native vertebrae and remainingnative annulus fibrosis, the expansile loop 48 may be filled with asuitable biologically compatible material. Such suitable materials thatcan be directly injected through the inner catheter control element 19if it includes a central lumen and openings connecting with the interiorchamber of the expansile braided, woven or embroidered loop asillustrated in FIG. 11. Alternatively, the biocompatible materials canbe injected using a separate catheter element which can be advancedalong the inner catheter control element into the interior chamber ofthe expansile braided, woven or embroidered loop. Alternatively, thebiocompatible materials could be injected into the interior chamber ofthe expansile braided, woven or embroidered loop using a separatecatheter or injection needle which pierces the side of the braided,woven or embroidered loop once it is expanded and in place in theinter-vertebral space. Biocompatible materials which may be injectedinclude biocompatible viscoelastic materials such as hydrophilicpolymers, hydrogels, homopolymer hydrogels, copolymer hydrogels,multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile,acrylic acid, acrylimide, acrylimidine, including but not limited toPVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinylalcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone,polyurethanes, polycarbonate-polyurethane (e.g., Corethane) otherbiocompatibile polymers, or combinations thereof. The viscosity of theinjected fluids must allow them to be injected either via catheter orneedle into the braided, woven or embroidered expansile loop. Theinjected biocompatible material must cure or polymerize in situ withinthe expansile braided, woven or embroidered loop and within the discspace. Such in situ curing of the biocompatible material may be theresult of mixing of multiple components and polymerization, temperaturechange in going from room to body temperature or elevated to bodytemperature, or other forms of energy such as light or electricityapplied to the injected material.

In addition, suitable materials that can be placed directed into theexpansile loop 48 and allowed to expand through the absorption ofliquids such as water include, but are not limited to, swelling hydrogelmaterials (e.g. polyacrliamide, polyacrylonitrile, polyvinyl alcohol orother biocompatible hydrogels). Examples of suitable materials for solidor semi-solid members include solid fibrous collagen or other suitablehard hydrophilic biocompatible material. The swelling of these materialsmay result in further expansion of the expansile braided, woven orembroidered loop and an increase in the inter-vertebral disc height.

In some cases, a multiphase system may be employed, for example, acombination of solids, fluids or gels may be used. Such materials maycreate primary and secondary levels of flexibility within the braided,woven embroidered expansile loop and within the vertebral disc space.

For example, the hydrogel materials (e.g. polyacrliamide,polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels orcombinations can be dissolved in a solvent, such as dimethylsulfoxide,analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate,acetone, glycerin or combinations thereof. Small amounts of water couldalso be added to the solvent/hydrogel combination to adjust thesolutions viscosity. This solvent/hydrogel combination can be injectedinto the inter-vertebral space to replace the nucleus, the annulus, orboth the nucleus and annulus. The expansile loop 48 will assist incontaining and supporting the solvent/hydrogel combination. Afterdelivery, the solvent is replaced by bodily fluids and the hydrogelprecipitates out of solution into a hydrated solid. The solvent isadsorbed into the body tissues. Introducing an aqueous solvent, such aswater or saline, into the inter-vertebral space containing thesolvent/hydrogel combination can be performed to increase theprecipitation speed of the hydrogel. This second step facilitates theprecipitation or solidification of the hydrogel material which swellsand fills the desired inter-vertebral space.

Once the expansile loop 48 is filled with a suitable material and thematerial has cured or partially polymerized, the inner catheter controlelement or filament 19 can be withdrawn by removing its distalconnection to the junction point with the outer catheter element 12 orat its termination within the braided, woven or embroidered expansileloop and pulling the inner catheter control element out of the expansileloop. Alternatively, the inner catheter control element 19 may be cutoff or disconnected at its entry point into the expansile loop. Thisleaves a complete toroid without defect, formed of the expansile loop inplace to act as an annular reinforcement or replacement which may or maynot surround an artificial nucleus device.

In another method of clinical use, after the braided, woven orembroidered expansile loop 48 has been expanded to its maximum diametricdimension, acting as a reinforcement or replacement for the damagednative annulus, the device may be centrally circumferentiallycontracted, as previously described, to fill any remaining spacepreviously occupied by the native nucleus prior to nuclectomy. Thebraided, woven or embroidered expansile loop 48 expands to the limits ofthe remains of disc space and the remains of the native nucleus andannulus and remains diametrically expanded and centrallycircumferentially contracted. Now the braided, woven or embroideredexpansile loop area may be filled with a biomaterial or any suitablematerial (as described above), as the present invention is not limitedin this respect. In addition to the materials disclosed for annulusreplacement, additional suitable fluid materials for nucleus and annularreplacement include, but are not limited to, various pharmaceuticals(steroids, antibiotics, tissue necrosis factor alpha or its antagonists,analgesics); growth factors, genes or gene vectors in solution; biologicmaterials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fator oils); synthetic polymers (polyethylene glycol, liquid silicones,synthetic oils); and saline.

Once the expansile loop is filled with a suitable material in thecentral and circumferentially contracted nuclear area and the annulararea, the inner catheter control element 19 can be withdrawn by removingits distal connection to the junction point with the outer catheterelement 12 and pulling the inner catheter control element out of theexpansile loop. Alternatively the inner catheter control element orfilament 19 may be disconnected from its attachment to the distal innerbraided, woven or embroidered expansile loop prior to its removal.Alternatively, the inner catheter control element or filament 19 may becut off at its entry point into the outer section of expansile loopusing a surgical tool. This leaves a complete toroid, without defect,formed of the expansile loop in place to act as an annular and nucleusreinforcement or replacement.

In another method of clinical use, the present invention can be advancedinto the vertebral space once a nuclectomy has been performed. Once thebraided, woven or embroidered expansile loop 24 is advanced into thevertebral space, it is diametrically expanded in the manner previouslydescribed. The braided, woven or embroidered expansile loop 25 expandsto the limits of the out portion of the remains of the native nucleusand remains diametrically expanded and transversely contracted. Now thebraided, woven or embroidered expansile loop 48 may be filled with abiomaterial of any suitable material, such as those previously noted, asthe present invention is not limited in this respect. This injectedmaterial is allowed to cure or polymerize to some extent, and then thecentral portion of the expansile loop is circumferentially contracted inthe manner previously described. At this point the central nuclear areaof the vertebral space is filled with the expanded mesh. This centralportion can then be filled with biomaterial or any suitable material,such as those previously noted, as the present invention is not limitedin this respect. In addition to the materials disclosed for annulusrepair or replacement, additional suitable fluid materials for nucleusreplacement include, but are not limited to, various pharmaceuticals(steroids, antibiotics, tissue necrosis factor alpha or its antagonists,analgesics); growth factors, genes or gene vectors in solution; biologicmaterials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fator oils); synthetic polymers (polyethylene glycol, liquid silicones,synthetic oils); and saline.

Once the braided, woven or embroidered expansile loop is filled with asuitable material in the nucleus area, the inner catheter controlelement 19 can be withdrawn by removing its distal connection to thejunction point with the outer catheter element 12 or its distalconnection with the distal inner expansile loop, and pulling the innercatheter control element 19 out of the expansile loop. Alternatively,the inner catheter control element or filament 19 may be cut off at itsentry point into the expansile loop using a surgical tool. This leaves acomplete toroid, without defect, formed of the expansile loop in placeto act as an annular reinforcement or replacement and/or nucleusreinforcement or replacement. It also allows the annular area of thedevice on the periphery and the nucleus portion of the device in thecentral region to have different physical properties dependent on thedifferential biocompatible materials injected into each region.

In an additional method of clinical use, once the nucleus of the dischas been removed, the present invention 10 is advanced into theinter-vertebral space. The braided, woven or embroidered expansile loop24 is diametrically expanded in the manner previously described. Thedistal interior braided, woven or embroidered expansile loop 25 ispulled out of the outer expansile loop and the overall expansile loopdiametrically expands to the limits of the inner portion of the nativeannulus. Next the inner catheter control element 19 is pulled back outof the expanded expansile loop and the inner potion of the innercatheter or filament loop 19 pulls in the inner circumference of theexpansile loop, making the central hole smaller and the braided, wovenor embroidered expansile loop 48 transversely wider to better fill thecentral defect in the vertebral space. This expanded braided, woven orembroidered expansile loop 48 may be used to contact a centralprosthetic nucleus previously placed in the middle of the braided, wovenor embroidered expansile loop. In the case where no additional nucleusprosthesis is desired, the central portion of the braided, woven orembroidered expansile loop can be been expanded to the point whereessentially no central hole 37 remains in the toroid. The fully expandedbraided, woven or embroidered expansile loop can now be injected with asuitable biocompatible material (as described above) which will expandor cure in situ as previously described. In this case the presentinvention will function as both a prosthetic annulus and a prostheticnucleus and its load bearing properties will be dependent on theproperties of the polymer chosen to fill the expansile loop.

Additionally, a hydrogel, polymer or biocompatible material may beinjected into the interior chamber of the expansile loop such that thebiocompatible material has the capacity to swell or increase in size asthe result of absorbing water or liquid. This would result in furtherexpansion of the expansile braided, woven or embroidered loop and anincrease in the inter-vertebral disc height.

In another method of clinical use, the intended treatment is to fuse twoadjacent vertebrae using the present invention 10. Again using theillustration in FIGS. 10, the end of the inner catheter control element19 is attached to the interior and distal end 22 of the braided, wovenor embroidered expansile loop 24. To expand the diameter of theexpansile loop one merely needs to stabilize the proximal portion orouter end 23 of the braided, woven or embroidered expansile loop andpull back the inner catheter control element or filament 19 or wire.This will result in the inner section of the braided, woven orembroidered expansile loop pulling out of the outer section of thebraided, woven or embroidered expansile spiral as the wire is retracted.Once the desired outer diameter of the braided, woven or embroideredexpansile loop 48 is achieved, the central portion of the braided, wovenor embroidered expansile loop 48 may be contacted by pulling the sameinner catheter control element 19 further back out of the proximalportion of the braided, woven or embroidered expansile loop. The innerloop portion of the inner catheter control element or filament 19 willcontract in diameter and pull on the inner circumference of the braided,woven or embroidered expansile loop 48 resulting in the central “hole”of the toroid becoming smaller and smaller in diameter 37. This resultsin the transverse diameter of the toroid becoming bigger while the outerdiameter stays the same. Once the desired size is reached, the wire maybe held in place and a polymeric or other biologically compatiblematerial as describe above injected into the toroid either through theinner catheter control element, which may be in the form of a hollowcatheter or hypotube, or alternatively via a catheter which is advancedinto the toroid along the inner catheter control element or filament 19or separately using a catheter or needle for injection. The fullyexpanded expansile loop 48 can now be injected or filled with a suitablematerial for fusing the two adjacent vertebrae together. Candidates fora suitable fusing material include, but are not limited to, bond graftmaterials such as any described “bone cements” or any polymeric bonegraft compounds, bone graft materials, nylon fibers, carbon fibers,glass fibers, collagen fibers, ceramic fibers, polyethylene fibers,poly(ethylene terephthalate), polyglycolides, polylactides, andcombinations thereof.

Once the bone fusing material has been injected the inner cathetercontrol element 19 may be removed by retracting it from the braided,woven or embroidered expansile loop. Alternatively, the inner cathetercontrol element 19 may be cut off at its entrance point into the toroid.In another embodiment (not illustrated) the expansile loop may beexpanded in diameter using an inner filament of sufficient stiffnesssuch as the metal wire described and the central hole may be madesmaller by pulling on a separate flexible filament such as a threadattached to the inner radius of the braided, woven or embroideredexpansile loop.

In this embodiment of fusing two adjacent vertebrae together, it may bedesirable to stimulate growth of bone through the fill material. Tofacilitate bone integration and growth, the expansile loop should haveopenings that are more porous. The pores or openings of the expansileloop will have a diameter of about 0.25 mm to about 5.0 mm. The size isselected to allow tissue in-growth while containing the material packedinto the expansile loop. It is also contemplated that the expansile loopcan be seeded in vitro with bone forming cells, such as osteoblasts,and/or with growth factors. Multiple layers of osteoblast-seededapplications may be stacked on top of one another and further allowed toor encouraged to proliferate. In addition to in vitro seeding ofosteoblasts, other treatments for the braided, woven or embroideredexpansile loop are contemplated that also provide an implant that allowsfor bone in-growth and regeneration of bony tissue. For example, theexpansile loop can be coated with a demineralized bone matrix or smearedor coated with an osteoinductive bone paste, such as OSTEOFIL™. Inaddition, the expansile loop can be coated with collagen, andsubsequently soaked in a pharmacological agent such as recombinant humanbone morphogenic protein, antibiotic agents, or other similar material.

An additional feature that can be incorporated to all of the embodimentsdisclosed herein is the means for attaching or securing the expansileloop or mesh 59, 60, 61, 62 to the surrounding disc structures, theannulus 36 and/or the native or artificial nucleus 34 or the vertebralendplates 35. One benefit of the described invention is that theattachment means 64 can secure the circumferential expansile loop ormesh 59, 60, 61, 62 to healthy tissue located away from a damaged areaor on the opposite side of the hernia or clinical entry site.

Shown in FIG. 23 is a cross sectional view of the attachment means 64 inthe from of a suture 66 and demonstrating a suture delivery system 68already advanced through an access tube 38 and utilizing non-absorbableor re-absorbable sutures 66 to attach the contracted configuration ofthe expansile mesh 59, 61 to the inner wall of the annulus 36 atmultiple points. Although not shown in FIG. 23, it is anticipated by theApplicants that the suture delivery system 68 can be used without theaccess tube 38 and can be advanced with or with the aid of endoscopethrough the access opening or potentially a hernia opening to performthe attachment procedure. Furthermore, other traditional surgical ormanipulation techniques not utilizing a delivery system 68 can be usedwith or without the aid of an endoscope through the access opening orpotentially a hernia opening to perform the attachment procedure.

The attachment means 64 for securing the expansile loop or mesh to theannulus 36 or native/artificial nucleus 34 could be through the use ofpreviously known technology such as sutures, clips, tacks, anchors,staples, screws, buttons, T-shaped tags, barbed tags, adhesives or othersimilar devices having appropriate securing characteristics. The term“attachment means” used herein encompasses sutures, clips, tacks,anchors, staples, screws, clamps, buttons, T-shaped tags, barbed tagsand other tissue holding means and delivery/manipulation techniques.

Whereby sutures 66 are known to be the standard in holding strength, theuse of tacks, staples and other fasteners continue to be developed andimplemented. Since the delivering, manipulating and retrieving a suture,often in a very tight surgical site is difficult the use and delivery ofnon-suture attachment means through a small opening to hold torn tissuehave been shown to have a clinical advantage.

FIG. 24 shows a cross sectional view of the attachment means 64 in theform of a staple or helicoil 70,71 with a delivery system 72 alreadyadvanced through the access tube 38 and utilizing non-absorbable orre-absorbable stables or helicoil mechanism 70 to secure the expandedexpansile mesh 60, 62 to the inner wall of the annulus 36 at multiplepoints. The staple or helicoil is being provided as an example in thisFigure since the attachment means 64 could be clips, tacks, anchors,staples, screws, clamps, buttons, T-shaped tags, barbed tags and othertissue holding means and delivery/manipulation techniques. Also shown inFIG. 24 is a cross sectional view of the a staple or helicoil deliverysystem 72 already advanced through the access tube 38 and utilizingnon-absorbable or re-absorbable stables or helicoils 71 to attach theexpanded expansile mesh 60, 62 to the outer wall of the native orartificial nucleus 34 at multiple points. Although not shown in FIG. 24,it is anticipated by the Applicants that the helicoil delivery system 72can be used without the access tube 38 and can be advanced with or withthe aid of an endoscope through the access opening or potentially ahernia opening to perform the attachment procedure. Furthermore, othertraditional surgical or manipulation techniques not utilizing a deliverysystem 72 can be used with or without the aid of an endoscope throughthe access opening or potentially a hernia opening to perform theattachment procedure.

The attachment means 64 is designed to engage the outer surface of theexpansile mesh and then engage the either the annulus 36 or the nucleus34, securing the expansile loop or mesh in place. Besides securing theexpansile mesh or loop in place, the use of an attachment means tosecure the expansile mesh or loop can facilitate the in-growth of newtissues.

The annulus/nucleus attachment means 64 could be installed within theexpansile mesh prior to insertion with the vertebral space. Alternatelythe annulus/nucleus attachment means 64 can be installed within theexpansile mesh after is inserted into the disc in a contactingconfiguration or after the mesh is expanded in the disc. Theannulus/nucleus attachment means 64 could be made from materials thatare biodegradable or bioabsorbable such as resorbable collagen, LPLA(poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA(polyglycolide), PGA-LPLA or PGA-DLPLA, polylactic acid and polyglycolicacid which is broken down and bioabsorbed by the patient over a periodof time.

Furthermore, as shown in FIG. 25, the expansile loop or mesh 60, 62could be expanded and secured to an endplate 35 a or 35 b or bothendplates 35 a and 35 b of the vertebral body. Also shown is annulartissue 36 sandwiched between the two vertebral endplates 35. Suchattachments means 64 are the same as the annulus 36 means but aredesigned for placement into hard bony tissues. This includes bonescrews, anchors, and other means 74 for attachment to hard tissue.

Attachment to the native nucleus could be required if a partialnuclectomy is performed. Attachment to an artificial nucleus 34 could beperformed following nuclectomy and placement of an artificial nucleus.Attachment of expansile mesh 60, 62 to the artificial nucleus 34 couldstabilize the artificial nucleus and/or maintain the artificialnucleus's position during delivery, during mesh expansion and over time.

Attachment of the expansile mesh 60, 62 to the annulus 36, native orartificial nucleus 34, or the endplates 35 could encourage in-growth ofbody tissues throughout the expansile mesh 60, 62 and therefore functionto reinforce and repair the annulus and strengthen the annulus ornucleus. Overall, the placement of the attachment means 64 into healthytissue will increase long-term stability.

One significant advantage of the described invention and attachmentmeans is that the attachment means may be placed into healthy annulartissue located distal to the annulectomy site or site of hernia defect.This is due to the complete circumferential nature of the expansile loopwithin the inner surface of the annulus. This is an advantage overpreviously described systems used to patch a hole created in the annulusin the area of a hernia defect or diseased tissue.

In addition, the expansile mesh 59, 60, 61, 62, can include materialsthat will act as a scaffold or carrier for delivering biologicmedicaments to vertebral tissues. The expansile mesh can be previouslytreated (for example, by soaking) with certain biologics (e.g. BMP,OP-1), or the access tube can be constructed to include a biologicdelivery means such that the biologic is 1) delivered while theattachment means 64 is being deployed, 2) delivered prior to deployingthe attachment means 64, 3) delivery subsequent to deploying theattachment means 64, or any combinations thereof.

In another method of clinical use, the several embodiments of thepresent invention can be advanced into the vertebral space once anuclectomy has been performed, as shown in FIG. 26. Once the braided,woven or embroidered expansile loop 24 is advanced into the vertebralspace (FIG. 27), it is diametrically expanded in the manner previouslydescribed and as shown in FIG. 28. The braided, woven or embroideredexpansile mesh 25 is expanded to the limits of the inner portion of thenative annulus and becomes diametrically expanded and transverselycontracted. In this clinical use, an inner central area 80 surrounded bythe inner surface of the expansile mesh is formed as the expansile meshis expanded and contracted. For the purpose of demonstration, a deliveryprobe 82 is inserted between some of the mesh layers of the expansileloop in an anterior approach (FIG. 28). It is anticipated and preferredthat the delivery probe 80 be inserted through the outer sheath 18 in aposterior or posterolateral approach (not shown).

FIG. 29 shows that the delivery probe 82 has been inserted through boththe outside and inside mesh layers, with its terminal end projectinginto the inner central area 80. Now the inner central area 80 may befilled with any suitable biomaterial, such as those previously noted, asthe present invention is not limited in this respect. This injectedmaterial is allowed to cure or polymerize to some extent, and then thecentral portion of the expansile loop is circumferentially contracted inthe manner previously described. Alternatively, the central toroidalarea 80 can be filled a suitable materials to induce bone fusionincluding, but are not limited to, bond graft materials such as anydescribed “bone cements” or any polymeric bone graft compounds, bonechips, bone graft materials, nylon fibers, carbon fibers, glass fibers,collagen fibers, ceramic fibers, polyethylene fibers, poly(ethyleneterephthalate), polyglycolides, polylactides, and combinations thereof,or a biomaterial or any suitable material (as described above), as thepresent invention is not limited in this respect.

A feature or characteristic of the present invention expansile mesh thathas been exemplified in FIGS. 16, 17, 23, 24, and 26-29, is that thebraided, woven or embroidered design and the flexibility of theexpansile loop or mesh allows the insertion of delivery probes and othersimilar devices without the need for a dedicated hole. As shown in FIG.30, the expansile mesh generally has a non-disturbed cross-pattern.Since the layers of this cross-pattern braided, woven or embroideredexpansile mesh are fabricated from a flexible material, when a deliveryprobe or similar device is inserted, the weave flexes and creates anopening between the individual layers, allowing for simple andeffortless penetration (see FIG. 31). When the delivery probe or similardevice is retracted from the expansile mesh, the individual layersreturn to their original undisturbed cross-pattern configuration, asshown in FIG. 30.

This design characteristic has several advantages. First, since there isno dedicated hole, penetration or insertion of a delivery probe can beaccomplished generally through any section of the expansile mesh withrelative ease. Hence, the clinician has the opportunity to attempt theinsertion of a delivery probe from various approaches, e.g. antegrade,posterior, and at various angles, thereby significantly increasing thepotential insertion sites and increasing the overall success of theprocedure. Second, since the mesh returns to its original undisturbedcross-pattern configuration after the probe or similar device has beenretracted, there is no hole or void that must be closed or sealed toprevent leakage of delivered biomaterials.

In an alternative embodiment of the current invention, the braided,woven or embroidered expansile loop may be looped around a bone graftsuch as a bone allograft, autograft, bone cage or the like, and advancedinto the vertebral space. As can be seen in FIG. 32 which shows a topview cross-section of a spinal body (vertebrae) 32 wherein one of theembodiments of the present invention's includes a bone block deliveryapparatus 95 having a shaft 90 that is coaxially engaged with a firsttubular member 92 and a second tubular member 93, further wherein theshaft member 90 has a terminal end with an attachment means 96temporarily engaged with a bone block 100 that is enclosed within thepresent invention expansile loop 10, 39, 43, 59, 61 in a contractedconfiguration. Next as shown in FIG. 33, one of the embodiments of thepresent invention's is used with the bone block delivery apparatus 95having a shaft 90 that is coxially engaged with a first tubular member92 and a second tubular member 93, further wherein the shaft member 90is temporally engaged to a bone block 100 that is enclosed within thepresent invention expansile loop 10, 39, 43, 59, 61 in a contractedconfiguration and being positioned within the inter-vertebral space 51.Then the expansile braided, woven or embroidered loop is thendiametrically expanded in the manner previously described and as shownin more detail in FIG. 34. The braided, woven or embroidered expansileloop 11, 40, 44, 59, 62 is expanded to the limits of the inner portionof the native annulus and becomes diametrically expanded andtransversely contracted by pulling the control elements 12. In the innercentral area 80 surrounded by the inner surface of the expansile meshnow contains the bone graft material. The expansile mesh is nowsubstantially centrally contracted around the bone graft in order tostabilize the bone graft and prevent displacement of the bone graft.

In FIG. 35 it is shown that the shaft member 90 has a terminal end withits attachment means 96 disengaged from a bone block 100 that isenclosed within the present invention expansile loop in a expandedconfiguration while positioned within the inter-vertebral space. As canbe seen from the example in this Figure, the attachment means 94 can bea treaded means with male thread 94 on the terminal end of the shaft 90designed to engage a female thread 97 in the bone block 100.

In FIG. 36 which is top view cross-section of a spinal body (vertebrae)32 wherein the shaft 90 is retracted, wherein the shaft 90 (shownretracted) or other instrument (not shown) urges the bone block 100 tomove from a vertical position 102 a to a horizontal position 102 b alongthe anterior wall of the annulus.

FIG. 37 demonstrates a top view cross-section of a spinal body(vertebrae) 32 with one of the embodiments of the present invention's11, 40, 44, 59, 62 delivers a plurality of materials 104 to the innercentral area 80 located in close proximity to the original vertebraenucleus area 53. Using either the first tubular member 92 of the boneblock delivery apparatus 95 or another delivery probe 82 that can beinserted between both or one layer of the expanded expansile loop 11,40, 44, 59, 62 in an anterior approach, posterior or posterolateralapproach. Suitable materials 104 to induce bone fusion including, butnot limited to, bone graft materials such as any described “bonecements” or any polymeric bone graft compounds, allograft, autograftbone chips, bone graft materials, nylon fibers, carbon fibers, glassfibers, collagen fibers, ceramic fibers, polyethylene fibers,poly(ethylene terephthalate), polyglycolides, polylactides, andcombinations thereof, or a biomaterial or any suitable material (asdescribed above), may now be inserted through the bone block deliveryapparatus 95 ot the delivery probe 82 and placed either into the centralarea 80 surrouding the central bone block 100 or cage or into the innerlumen of the toroid created by the previously expanded expansile mesh11, 40, 44, 59, 62. The expansile loop may now contract centrally usingthe control elements in the manner previously described. This results incompression of the bonegraft materials and bone block together. Thiswould result in increased stability of the bone graft materials,increased pressure against the endplates to augment fusion and increasedresistance to displacement or pullout of the bone block and chips.

It should be understood that the foregoing description of the presentinvention is intended merely to be illustrative thereof and that otherembodiments, modifications, and equivalents of the invention are withinthe scope of the invention recited in the claims appended hereto.Further, although each embodiment described above includes certainfeatures, the invention is not limited in this respect. Thus, one ormore of the above-described or other features of the invention, methodof delivery, or injection of biomaterial may be employed singularly orin any suitable combination, as the present invention is not limited toa specific embodiment.

1. A method for treating an inter-vertebral disc in a patient's spine,the disc having an annulus and a nucleus, the method comprising:inserting a circumferentially expandable device into the inter-vertebralspace to repair or reinforce a damaged annulus or replace a damagednucleus, said expandable device comprised of a mechanical expandablecontinuous mesh loop and a control element, said expandable mesh loopmechanically expanded or contracted with said control element withoutpressurization; positioning said mechanically expandable continuous meshloop within said annulus such that said expansile loop substantiallyencircles the inside of the annulus; and mechanically expanding saidexpandable continuous mesh loop substantially circumferentially withinsaid annular space using said control element that interacts with saidmesh for expanding or contracting, said expanded mesh having an insidesurface whereby expanding said expansile loop forms an inner centralarea.
 2. The method of treating inter-vertebral disc as recited in claim1 including the step of subsequently delivering and injecting a suitablebiocompatible material into said inner central area to replace at leasta portion of said damaged nucleus tissue.
 3. The method of treatinginter-vertebral disc as recited in claim 2, wherein said biocompatiblematerial is formed of a material selected from the group consisting ofhydrophilic polymers, hydrogels, homopolymer hydrogels, copolymerhydrogels, multi-polymer hydrogels, or interpenetrating hydrogels,acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but notlimited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethyleneoxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone,silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane)other biocompatibile polymers, or combinations thereof.
 4. The method oftreating inter-vertebral disc as recited in claim 2, wherein saidbiocompatible material is formed of a material that is allowed to expandthrough the adsorption of liquids such as water selected from the groupconsisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol orother biocompatible hydrogels, solid fibrous collagen or other suitablehydrophilic biocompatible material or combinations thereof.
 5. Themethod of treating inter-vertebral disc as recited in claim 2, whereinsaid biocompatible material is formed of a material selected from thegroup consisting of steroids, antibiotics, tissue necrosis factor alphaor its antagonists, analgesics, growth factors, genes or gene vectors insolution; biologic materials (hyaluronic acid, non-crosslinked collagen,fibrin, liquid fat or oils); Synthetic polymers (polyethylene glycol,liquid silicones, synthetic oils), saline or combinations thereof. 6.The method of treating inter-vertebral disc as recited in claim 2,wherein said biocompatible material is formed of a material selectedfrom the group consisting of bone graft materials such as any described“bone cements” or any polymeric bone graft compounds, bone graftmaterials, bone chips, nylon fibers carbon fibers, glass fibers,collagen fibers, ceramic fibers, polyethylene fibers, poly(ethyleneterephthalate), polyglycolides, polylactides, and combinations thereof.7. The method of treating inter-vertebral disc as recited in claim 1,wherein said spinal disc device is adapted to promote spinal fixationbetween two adjacent vertebral bodies.
 8. The method of treatinginter-vertebral disc as recited in claim 1, wherein said spinal discdevice is substantially circumferentially deformable to conform to aninterior region of a vertebral disc.
 9. The method of treatinginter-vertebral disc as recited in claim 1, wherein said spinal discdevice is adapted to inject a volume of biocompatible material into saidinner central area of said expansile loop until a desired disc height isachieved.
 10. The method of treating inter-vertebral disc as recited inclaim 1, wherein said spinal disc device is adapted to inject a volumeof biocompatible material into said inner central area of said expansileloop until a desired disc pressure is achieved.
 11. A method fortreating an inter-vertebral disc in a patient's spine, the disc havingan annulus and a nucleus, the method comprising: enclosing a biomaterialwithin an internal chamber of a circumferentially configured continuousexpansile mesh loop resulting in a preloaded expansile loop; advancingsaid preloaded expansile loop device into the inter-vertebral space torepair or circumferentially reinforce a damaged annulus or nucleus; andmechanically circumferentially expanding, without pressurization, saidpreloaded expansile loop by using a control element, said preloadedexpansile loop circumferentially expanding within said inter-vertebralspace to inner portion of the native annulus whereby a bone allograft,autograft or bone cage is maintained within the inner portion of theexpansile loop.
 12. The method of treating inter-vertebral disc asrecited in claim 11, wherein said biomaterial is formed of a materialselected from the group consisting of hycirophilic polymers, hydrogels,homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, orinterpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide,acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP,polyacrylainides, poly(ethylene oxide), polyvinyl alcohol,polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes,polycarbonate-polyurethane (e . g., Corethane) other biocompatibilepolymers, or combinations thereof.
 13. The method of treatinginter-vertebral disc as recited in claim 11, wherein said biomaterial isformed of a material that is allowed to expand through the adsorption ofliquids such as water selected from the group consisting ofpolyacrliamide, polyacrylonitrile, polyvinyl alcohol or otherbiocompatible hydrogels, solid fibrous collagen or other suitablehydrophilic biocompatible material or combinations thereof.
 14. Themethod of treating inter-vertebral disc as recited in claim 11, whereinsaid biomaterial is formed of a material selected from the groupconsisting of bone graft materials such as any described “bone cements”or any polymeric bone graft compounds, bone graft materials, bone chips,nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramicfibers, polyethylene fibers, poly (ethylene terephthalate),polyglycolides, polylactides, and combinations thereof.
 15. The methodof treating inter-vertebral disc as recited in claim 11, wherein saidspinal disc device is adapted to promote spinal fixation between twoadjacent vertebral bodies.
 16. The method of treating inter-vertebraldisc as recited in claim 11, wherein said spinal disc device isdeformable to conform to an interior region of a vertebral disc.
 17. Anapparatus for treating an inter-vertebral disc in a patient's spine,comprising: An internal shaft member; said shaft member having aproximal end and a terminal end, said terminal end fitted with a firstattachment means; an inner tubular member, said inner tubular member incoaxial alignment with said shaft member, said inner tubular memberhaving a proximal end and a terminal end; an outer tubular member, saidouter tubular member surrounding at least a portion of said innertubular member, said outer tubular member having a proximal end and aterminal end; an expansile continuous mesh loop, said expansile meshloop having one or more control elements, said one or more controlelements functioning to expand or contract said expansile mesh by actingon said mesh loop without pressurization, said expansile mesh exitingsaid terminal end of said inner tubular member; and said controlelements in close proximity to said expansile mesh entering from saidterminal end of said outer tubular member and extending the longitudinallength of said outer tubular member.
 18. An apparatus for treating aninter-vertebral disc in a patient's spine, comprising; An internal shaftmember; said shaft member having a proximal end and a terminal end, saidterminal end fitted with a first attachment means; an inner tubularmember, said inner tubular member in coaxial alignment with said shaftmember, said inner tubular member having a proximal end and a terminalend; an outer tubular member, said outer tubular member surrounding atleast a portion of said inner tubular member, said outer tubular memberhaving a proximal end and a terminal end; a circumferentially continuousexpansile mesh loop, said expansile mesh having one or more controlelements, said expansile mesh exiting said terminal end of said innertubular member; said control elements in close proximity to saidexpansile mesh entering from said terminal end of said outer tubularmember and extending the longitudinal length of said outer tubularmember; a bone block or bone cage, said bone block or bone cage having asecond attachment means on one side; and said second attachment meansdesigned to become temporarily engaged with said first attachment means.